Effects of gender, Helicobacter pylori and hepatitis B virus serology status on cardiovascular and renal complications in Chinese type 2 diabetic patients with overt nephropathy.

BACKGROUND: The aim of this study was to investigate whether chronic infections with Helicobacter pylori and hepatitis B virus (HBV) might affect clinical outcomes in Chinese type 2 diabetic patients with advanced nephropathy. METHODS: A prospective study of 97 type 2 diabetic patients with clinical proteinuria and renal insufficiency (median serum creatinine 200 micro mol/l). RESULTS: During a median follow-up period of 2 years, 34 developed end-stage renal disease (ESRD), 28 had cardiovascular endpoints and 11 patients had died (seven men and four women), and 52.7% developed a combined endpoint. Female patients had longer disease duration, higher blood pressure, lower body weight but higher serum creatinine and spot urine albumin : creatinine ratio as well as lower haemoglobin than male patients. On logistic regression analysis, female gender (hazard ratio: 5.91, p = 0.02), negative H. pylori serology (8.39, p = 0.004), baseline serum creatinine (1.04, p = 0.001) and haemoglobin (1.86, p = 0.01) were independent predictors for ESRD. Systolic blood pressure (1.04, p = 0.003), prior treatment with angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists (3.41, p = 0.04) and positive hepatitis B surface antigen (4.88, p = 0.025) were independent predictors for cardiovascular endpoints. Female gender (7.89, p = 0.002) and baseline serum creatinine (1.05, p < 0.001) were independent predictors for combined death and cardio-renal endpoints. CONCLUSIONS: In Chinese type 2 diabetic patients with clinical proteinuria renal insufficiency, there were high rates of death and cardio-renal outcomes. Female gender, low haemoglobin and negative H. pylori serology were important predictors for ESRD, whereas chronic HBV infection was associated with increased cardiovascular risks.

Oseltamivir prophylaxis during the influenza season in a paediatric cancer centre: prospective observational study.

OBJECTIVE: To determine the role of oseltamivir prophylaxis for immunocompromised patients. DESIGN: Prospective, non-blinded, non-controlled observational study. SETTING: A paediatric cancer centre, Hong Kong. PARTICIPANTS: Thirty-two patients, immunocompromised by chemotherapy or bone marrow transplantation during an influenza season in 2001. INTERVENTION: Oral oseltamivir prophylaxis 75 mg/d for 8 weeks. MAIN OUTCOME MEASURES: Laboratory-confirmed influenza infection, symptoms of influenza, drug compliance, and any side-effects from oseltamivir treatment. Laboratory monitoring included virological surveillance for influenza A and B, blood counts, and renal and liver function tests. RESULTS: Patients' median age was 14.3 years (range, 6.3-23.4 years). Underlying conditions included malignancy (n=29) and other haematological diseases (n=3). No documented influenza infection according to serological tests was present throughout the study period. Five patients with symptoms of upper respiratory tract infection did not have any influenza infection detected by rapid virological assay and viral culture. For 16% of patients, the main side-effect in the study was gastro-intestinal upset. CONCLUSIONS: Oral oseltamivir 75 mg once daily for 8 weeks may be useful in the prevention of influenza infection in patients immunocompromised by chemoradiotherapy; side-effects are few and acceptable.

Clinical course after stopping lamivudine in chronic hepatitis B patients with lamivudine-resistant mutants.

BACKGROUND: The efficacy of lamivudine therapy in chronic hepatitis B is well established. However, drug-resistant YMDD mutants emerge with extended therapy. This may result in the resurgence of viral replication, the return of hepatitis and histological deterioration. AIM: To study the safety of stopping lamivudine when the drug is no longer effective. METHODS: In the 5-year Asian Lamivudine Study, 34 patients from a single centre were included in this study. They had harboured YMDD mutants for at least 2 years. Lamivudine was discontinued and they were followed up at regular intervals. Clinical symptoms, liver biochemistry and viral serology were monitored. RESULTS: In a median follow-up of 20 months after stopping lamivudine (range, 7-39 months), 20 of the 34 patients (58.8%) had elevated alanine aminotransferase (ALT), 13 patients (38.2%) had elevated ALT one to five times the upper limit of normal and seven patients (20.6%) had an ALT flare (ALT more than five times the upper limit of normal with detectable hepatitis B virus DNA). There was no liver decompensation. ALT flare could be predicted by ALT over twice the upper limit of normal at the time of stopping lamivudine (P = 0.037). CONCLUSIONS: It is relatively safe to stop lamivudine after YMDD mutants have emerged. ALT levels greater than or equal to twice the upper limit of normal at the time of stopping lamivudine have a higher risk for ALT flare.

Relationship of clinical and virological factors with hepatitis activity in hepatitis B e antigen-negative chronic hepatitis B virus-infected patients.

To investigate the factors associated with active disease among hepatitis B surface antigen (HBsAg) positive/hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection we studied chronic HBV infected patients who had undetectable HBeAg at the first visit. HBV DNA was determined by the cross-linking assay (NAXCOR) and polymerase chain reaction (PCR). Mutations in the core promoter and precore regions and viral genotypes were studied. Clinical outcome of these patients were followed and categorized as: (i) relapse (ALT > 200 IU/L or three times the previous levels); (ii) active hepatitis (elevated ALT < 200 IU/L with concomitant detectable HBV DNA); or (iii) remission. A total of eighty-five patients were followed up for 5.5 +/- 1.0 years. At first visit, 31 (36.5%) patients had elevated ALT levels, 12 (14.1%) had measurable HBV DNA by the cross-linking assay and 26 (30.6%) by PCR. Sixteen (18.8%) patients had hepatitis relapse, 13 (15.3%) had active hepatitis, and 56 (65.9%) remained in remission. Core promoter and precore stop codon mutants were found in 27 and 12 patients, respectively. Eleven and 20 had genotype B and C HBV, respectively. Initial elevated ALT and detectable HBV DNA were associated with active liver disease. Patient demographics, viral mutants or genotypes failed to predict disease activity. Hence, serum ALT and HBV DNA levels offer the best prediction of natural course of HBeAg-negative chronic HBV infection.